PETITION TO ENACT ORPHAN DRUG ACT IN CANADA

PETITION TO THE HOUSE OF COMMONS IN PARLIAMENT ASSEMBLED
WE THE UNDERSIGNED ALL CITIZENS AND RESIDENTS OF CANADA RESPECTFULLY WISH TO BRING TO YOUR ATTENTION THE FOLLOWING FACTS:
- that there is presently no Orphan Drug Act in place in Canada;
- that the Orphan Drug Act would greatly enhance the ability of people afflicted with rare diseases access to medicines which are medically necessary to treat their specific rare illnesses, and which they would otherwise not have at their disposal. The enactment of such an act by the United States of America, Japan, and specific countries in the European Union, who have taken the liberty of enacting an Orphan Drug Act, has been posted and recognized by Health Canada website as provided by the link at http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/pol/orph_pol_e.html;
- that the United States of America, Japan, and specific countries in the European Union have an Orphan Drug Act in place, which has ensured that all people afflicted with rare diseases have access to Orphan-designated medicines in their respective countries. Therefore, the benefits for all people afflicted by rare diseases in Canada would increase exponentially thus allowing access to drug(s) which would not normally be available to them under the same and/or similar circumstances;
- that the Orphan Drug Act (1983) which was signed into law on January 4, 1983 in the United States of America has resulted in the development of nearly 250 Orphan-designated medicines which are now available to treat a potential patient population of more than 12 million Americans. In contrast, the decade prior to 1983 saw fewer than 10 such products developed without government assistance. As a result, treatments are now available to people afflicted with rare diseases who once had no hope for survival;
- that the Orphan Drug Act would create financial incentives for drug and biologic manufacturers which would include tax credits for costs of clinical research, government grant funding, assistance for clinical research, and a possible seven-year period of exclusive marketing given to the first sponsor of an Orphan-designated medicine(s) who obtain(s) marketing approval from Health Canada for the same indication;
- that the Orphan Drug Act would allow for accelerated or early approval policy that allows for faster approval of therapies that treat serious or life-threatening illnesses. Accelerated approval would be granted when favorable results in early studies indicate outcomes that are likely to predict long-term clinical benefit. A key part of the accelerated approval process would involve further study of any new treatment after approval to confirm clinical benefit and in-depth review of medically documented facts pertaining to the designated medicines efficacy, further enhancing the commercial viability and/or potential to develop drugs or therapies for those suffering from, and afflicted with rare diseases;
- that the Orphan Drug Act would take into account, and allow for the production of topical, oral, and intravenous drugs or medicines for some or all rare diseases since rare diseases take on many forms which manifest both externally or internally in the human body, thereby ensuring that all rare diseases have various forms of treatment, which will in turn prevent life-threatening organ damage and have a positive health effect on the people suffering from, and afflicted with rare diseases;
- that Health Canada be appointed the governing body of all drugs and medicines to treat rare diseases, thereby ensuring the Orphan Drug Act is regulated and adopted by all divisions under its umbrella, and strictly adhered to under the Laws of Canada;
- that Health Canada will work closely with the product developer(s) to ensure that, despite the relatively small number of patients with rare diseases, all reasonable steps will be pursued in the manufacture and distribution of topical, oral and intravenous drugs or medicines, ensuring that the knowledge obtained with respect to Orphan-designated medicines to treat rare diseases is shared about each product's clinical benefits, efficacy, and long-term safety, once it is on the market;
- that the plight of Canadians of all ages, and from all walks of life, that have been afflicted with rare diseases, have the inalienable right to drugs and medicines which are constitutionally and medically necessary to their health, longevity, well-being, existence, and deserve more attention by the enacting of an Orphan Drug Act in Canada;
- that we as Canadians have a constitutional right to Orphan-designated products, as well as to the enactment of an Orphan Drug Act with respect to, and in light of same;
- that an Orphan Drug Act in Canada would benefit and greatly enhance the lives of people afflicted with rare diseases now and well into the future, thus creating a precedent for all countries to follow, in due course and with due diligence.
THEREFORE, YOUR PETITIONERS RESPECTFULLY WISH TO CALL UPON THE HOUSE OF COMMONS TO:
Enact an Orphan Drug Act in Canada for individuals afflicted and suffering from the detrimental and long-term effects of rare diseases, and who are deserving of your compassion and empathy.

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